Signore A.A., Jacobs T. (Eds) Good Design Practices for GMP Pharmaceutical Facilities

Boca Raton: Taylor & Francis Group. - 2005. - 550 p. A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, design, build, validate, and implement pharmaceutical plant and system designs—demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.
An experienced panel of leading design professionals and consultants provide recommendations, references, and practical advice for high-quality and cost-effective pharmaceutical manufacturing operations.
This handbook spans a wide range of topics central to the successful performance of pharmaceutical oral solid, sterile product, bioprocess, active pharma ingredient, clinical material, and regulated facilities.contains essential background information and solutions to common challenges in the layout and formation of manufacturing facilities that must comply with current codes, statutes, and regulations in industry.addresses emerging trends in process technology.contains practical suggestions that illustrate best practices in the planning and delivery of facilities that perform and conform to current regulatory requirements and business imperatives.and enriches decision-making by emphasizing scope development, master planning, and clear design execution.AdvisorsPharmaceutical Industry Profile
Current Good Manufacturing Practices
Facility Planning
Architecture
Mechanical Utilities
High Purity Water
Automation and Process Controls
Validation and Facility Design
Process Engineering
Oral Solid Dosage Facilities
Sterile Manufacturing Facilities
Biotechnology Facilities
API Facilities
Building Code Compliance
Containment/Isolation
Occupational Health and Safety
Technology Transfer
Environmental Considerations
Support Laboratories
Packaging/Warehousing